Chapter 1Introduction
1.1On 9 March 2023, the Improving Access to Medicinal Cannabis Bill 2023 (thebill) was introduced to the Senate by Senator Malcolm Roberts.
1.2On 23 March 2023, the Senate referred the bill to the Senate Community Affairs Legislation Committee (the committee) for inquiry and report by 1September2023.
Structure of the report
1.3This report contains two chapters. This chapter sets out:
the purpose of the bill;
background information on medicinal cannabis and the existing regulatory framework;
an overview of the bill’s key provisions; and
general information outlining the conduct of the inquiry and other committees’ consideration of the bill.
1.4Chapter two examines the key issues raised by submitters and concludes with the committee’s view and recommendation.
Purpose of the bill
1.5This bill would amend the Therapeutic Goods (Poisons Standard–February 2023) Instrument 2023 (the Poisons Standard) and aims to improve the availability of medicinal cannabis for Australian consumers and their pets. Asoutlined by Senator Roberts, the bill seeks to improve access to medicinal cannabis in four ways:
broadening the scope of medical practitioners who can prescribe medicinal cannabis to include any prescribing medical practitioner;
increasing the allowed amount of tetrahydrocannabinol (THC) in unregulated hemp products from 0.1% to 1%;
allowing cannabis products with THC levels below 1% and cannabidiol (CBD) below 10% to be sold over the counter by pharmacists and veterinarians; and
adding hemp seed as a food product that is exempt from classification.
Background
Cannabis and its medicinal uses
1.6Cannabis is a type of plant that contains compounds known as cannabinoids. Cannabinoids can have medicinal properties, and the two most naturally occurring cannabinoids in cannabis are CBD and THC.
1.7Both THC and CBD are found in the plant’s flowering top and in its resin. THCis a psychotropic substance (i.e. an intoxicant) and is the reason that cannabis is used recreationally. Some of its medicinal effects may include reducing nausea, vomiting, pain and muscles spasms, as well improving sleep and appetite. CBD is non-psychoactive, and may be useful in managing seizures, pain, anxiety, and may also have antipsychotic effects.
1.8Concentration of CBD and THC varies between different strains of the plant, with different concentrations of cannabinoids leading to different psychoactive effects and therapeutic benefits.
1.9Products containing CBD and THC can be administered in various ways, including sprays, ointments and vaporisation, but are most commonly administered to patients as capsules, tablets and extracts or tinctures.
Existing legislation and regulatory frameworks
1.10Legislative changes to the regulation of medicinal cannabis have occurred over the last decade, where controls have been relaxed to increase access.
1.11In 2016, Parliament passed legislation to allow regulated cultivation, production and manufacture of cannabis for medical or scientific purposes. Further change occurred in 2018 via regulations that permitted the exportation of Australian medicinal cannabis products.In 2021, licencing and permit requirements also changed to simplify and clarify these requirements.
1.12In addition to these legislative changes, the provision of medicinal cannabis to patients within Australia is complemented by various regulatory frameworks. These are examined below.
Accessing registered and unregistered medicinal cannabis products
1.13Various frameworks regulate how the Australian public can access medicinal cannabis. Currently, Australians can access two medicinal cannabis products without having to engage in alternate prescription pathways.
1.14Access to medicines is managed by the Therapeutic Goods Administration (TGA), who administers the Therapeutic Goods Act 1989 (TG Act). The object of the TG Act is to:
Provide for the establishment of maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods…
1.15The Australian Register of Therapeutic Goods (ARTG) operates within the national system of controls that the TGA administers. Medicines can be lawfully supplied in or exported from Australia once they have been 'registered' or 'listed' on the ARTG. The person or company that exports, imports, or manufactures the medicine, or arranges for such processes to occur, must apply to the TGA for a medicine to be listed. This person or company is referred to as a sponsor. For a medicine to be successfully listed, it must be subject to pre‑market scrutiny and the sponsor must certify that the medicine meets all appliable standards. Once listed on the ARTG, the medicine can be lawfully supplied to consumers.
1.16Currently, only two medicinal cannabis products are registered on the ARTG for supply in Australia. Sativex, containing nabiximols (a cannabis extract), was registered in 2012 and is indicated to treat spasticity in patients with Multiple Sclerosis. Epidyolex, containing CBD, was registered in 2020 and is indicated to adjunctly treat patients two years and older who suffer from seizures associated with Lennox-Gastaut Syndrome or Dravet Syndrome. The Australian Medicinal Cannabis Association explained that, apart from Sativex and Epidyolex, most medicinal cannabis products lack the necessary efficacy and safety data to be registered.
1.17Australian consumers who wish to access medicinal cannabis products that are unregistered may do so through established access pathways under the TG Act, including the Special Access Scheme (SAS) and the Authorised Prescriber Scheme (APS).
1.18Under the SAS, medical practitioners can apply to prescribe unregistered medicinal cannabis products to a patient. The SAS Category A pathway is used to prescribe an unapproved medicinal cannabis product to a seriously ill patient. Practitioners can also apply through the SAS Category B (SAS-B) pathway, thus allowing them to prescribe on a case-by-case basis where they have an appropriate justification as to why a registered product is not suitable for treatment.
1.19Alternatively, practitioners can become an Authorised Prescriber, in which the TGA grants a practitioner the authority to prescribe a specific unregistered medicinal cannabis product to a class of patients under their immediate care.
1.20The Australian Medicinal Cannabis Association reported that since 2016, 1,157,195 patients have accessed medicinal cannabis products under the SAS-B pathway, and that there have been 344,695 approvals under the AP scheme.
The Pharmaceutical Benefits Scheme
1.21The Pharmaceutical Benefits Scheme (PBS) lists medicines available to consumers that are government subsidised. Generally, a medicine is not listed on the PBS if it is not listed on the ARTG.
1.22Currently, one medicinal cannabis product is listed on the PBS. In May 2021, Epidyolex was listed on the PBS in conjunction with at least two other anti‑epileptic medicines.
The Poisons Standard
1.23The Poisons Standard is a legislative instrument, with the current iteration being the Therapeutic Goods (Poisons Standard–July 2023) Instrument 2023. ThePoisons Standard categorises substances into schedules according to their intended use(s), potential for harm and the level of required access control to protect public health. Schedules range from one to ten, with Schedule 1 referring to medicines and chemicals that are not currently in use, and Schedule 10 referring to substances that are of such danger to health that they warrant prohibition of sale, supply and use.
1.24The Secretary of the Department of Health and Aged Care possesses the power to make scheduling decisions. However, in practice, this power is typically exercised by a delegate of the Secretary. Decisions are made based on a variety of factors, including the benefits and risks associated with using the relevant substance and the potential for substance abuse. The Secretary or their delegate also receives advice from two committees: the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling. These committees make recommendations to the Secretary, after public consultation, on the appropriate level of scheduling for medicines and chemicals.
1.25Currently, most medicinal cannabis products are Schedule 8 'controlled drugs', which means these substances should be available for use but require restrictions to reduce abuse, misuse and dependence. Some cannabis products that contain mainly CBD are in Schedule 4 (prescription-only) as well as Schedule 3 (available from pharmacists without a prescription). Schedules 4 and 8 also include veterinary medicines.
1.26The Poisons Standard and its accompanying scheduling rules are given legal effect through state and territory legislation, which regulate matters pertaining to the storage, prescription, supply and use of medicines in their jurisdictions.
1.27The scheduling of substances under the Poison Standard, the listing of goods on the Register, and the listing of medicines on the PBS are all independent processes.
Key provisions of the bill
1.28The bill is comprised of one schedule that would amend the Therapeutic Goods (Poisons Standard–February 2023) Instrument 2023.
1.29Schedule 1 of the bill would alter the entry for cannabidiol in Schedule 3 (pharmacist only medicines) of the Poisons Standard to:
extend the entry to include topical preparations alongside the existing oral, oromucosal and sublingual scheduled preparations;
place a limit on CBD content within a preparation to 10%, as there is currently no limit placed on CBD content; and
state that cannabinoids, including CBD, must be only those naturally found in cannabis. The existing entry states that CBD does not have to be naturally found in cannabis, thus allowing for synthetic CBD.
1.30Schedule 1 would also reschedule the entries for cannabis, nabiximols and non‑synthetic THC from Schedule 8 (controlled drugs) to Schedule 4, thereby relaxing controls to allow any medical practitioner to prescribe these medicinal cannabis products. The explanatory memorandum states that this would allow for the inclusion of medicinal cannabis products on the PBS as a separate process.
1.31Further, the entries for cannabis and THC in Schedule 9 would be amended. The new entry would exclude products that contain less than 1% of THC content, thereby increasing the current limit of 0.1%. The explanatory memorandum states that this increase to 1% is still below the level for any hallucinogenic response and harmonises Commonwealth law with state and territory laws, which have all set a limit of 1%.
1.32If passed by the Parliament, the provisions would commence the day after the Act receives Royal Assent.
Compatibility with human rights
1.33The statement of compatibility with human rights in the bill’s explanatory memorandum states that the bill is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
1.34The statement notes that the bill promotes the right to health, the right to work and the right to privacy through its proposed amendments.
Consideration by other committees
1.35The Parliamentary Joint Committee on Human Rights made no comment on the bill in its Report 4 of 2023.
1.36The Senate Standing Committee for the Scrutiny of Bills made no comment on the bill in its Scrutiny Digest 3 of 2023.
Community Affairs References Committee inquiry
1.37In March 2020, the Community Affairs References Committee tabled its final report into the current barriers to patient access to medicinal cannabis in Australia.
1.38The committee received 146 submissions and made 20 recommendations aimed at improving patient access to medicinal cannabis. The Australian Medicinal Cannabis Association commented that most of the recommendations have not been actioned.
Financial impact statement
1.39The explanatory memorandum does not outline any financial implications of the changes proposed in this bill.
Conduct of the inquiry
1.40Details of the inquiry were made available on the committee’s website.The committee contacted organisations and individuals to invite them to make a submission to the inquiry by 5 May 2023. The committee received 20 submissions, which are listed in Appendix 1.
1.41The committee thanks the organisations and individuals that made submissions for their contributions to the inquiry.